- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04950062
High Intensity Interval Training Versus Intermittent Fasting on Functional Capacity Among Overweight Subjects
Effect of High Intensity Interval Training Versus Intermittent Fasting 16/8 Protocol on Functional Capacity Among Overweight Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Exercise improves cardiorespiratory fitness, muscle strength, endurance, body composition, and decreases visceral fat. The, increase in physical activity and modification of eating behaviors are the first line of interventions given because of their low costs and low risks of complications.
Most commonly, the continuous exercise of moderate intensity, that has to be performed several days of the week to get target benefits have been used, on the other hand, different forms of training which aim to reduce time spent exercising by increasing exercise intensity have been considered as an alternative to increasing adherence to the training program which is supported by some researches that may have greater benefits as high intensity interval training improves the vascular function of the muscle capillary density and endothelial nitric oxide synthase(eNOS) levels. But there are some overweight people even some of the young people have restriction to perform exercise programs due to any medical problem that could interfere with exercise.
So, searching for optimal dietary interventions for obesity is still ongoing, but the modification in eating behaviors are hampered by difficulties in coping with a different diet. So, the diet with a fasting component that will be used in this study may be more effective than other complex and restrictive diets as it essentially limits the caloric intake to a specified period without major diet composition changes.
So, the aim of this study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Damietta, Egypt, 34518
- Outpatient clinic - Faculty of Physical Therapy - Horus University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects have to meet all the following criteria in order to participate in the study:
- Overweight subjects with age from 25 to 35 years.
- Body mass index will be range from 25 to 29.9 kg/m2.
- Waist circumference ≥ 80 cm2.
- A minimum of 70% of exercise program and diet regimen compliance will be required in order to be included.
Exclusion Criteria:
Subjects with the following disorders will be excluded from participating in this study:
- Musculoskeletal, cardiovascular disorders.
- Asthma, chronic obstructive pulmonary diseases.
- Any systemic disease or condition that might reduce adherence or tolerance to exercise or fasting.
- History of stroke.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: High intensity interval training
Group A included 30 subjects who will participate in high intensity interval training on a treadmill for 12 weeks, 3 times/week.
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Active Comparator: Intermittent fasting
Group B that included 30 subjects will participate in intermittent fasting for 12 weeks, 3 times/week.
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Every subject will be instructed to fast a fixed 16 hours followed by 8 hours of eating every day through the whole study period based on their life and sleeping style.
During fasting, zero-calorie coffee, tea and water intake will be permitted.
Beverages containing calories were consumed during the feeding hours each day.
All subjects will be instructed about their optimum caloric requirement based on their basal metabolic rate that will be calculated in advance to avoid over consumption of food on severe caloric restriction as we like to investigate the effect of this way of fasting on reducing weight and improving functional capacity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessing the change in Vo2max
Time Frame: Baseline and 2 months post-intervention
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Assessment via using Standard Bruce protocol will be used to measure (VO2) max.
The Bruce protocol for multi stage treadmill testing of maximal exercise will be used.
This will begin with stage 1 with walking slowly for three minutes at 2.7 Km/hr at a 10% grade (inclination), speed and grade then increased in every stage of 3 minutes and end at stage 7 or till exhaustion.
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Baseline and 2 months post-intervention
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Assessing the change in body weight
Time Frame: Baseline and 2 months post-intervention
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Assessment via using of body weight scale with height (m) scale to be able to calculate body weight (Kg).
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Baseline and 2 months post-intervention
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Assessing the change in waist hip circumference
Time Frame: Baseline and 2 months post-intervention
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Assessment via using Tape measures It will be used to measure waist and hip circumference and calculate waist hip ratio
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Baseline and 2 months post-intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manar Elbaz, Demonstrator, Horus University in Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Manar_MSc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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